Cleaning Validation Engineer - Katalyst Healthcares & Life Sciences
Largo, FL 33770
About the Job
Lead development and maintenance of cleaning validation strategy compliant with US FDA requirements.
Create cleaning cycle development programs for a variety of equipment including process vessels, clean-in place systems, packaging equipment, parts washers, and production facilities.
Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes.
Lead investigation and troubleshooting problems which occur during cleaning.
Responsible for planning and execution of onsite cleaning validation programs.
Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval.
Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.
Collaborate with other departments to define protocol contents and actions.
Develop and author change controls for cleaning process or equipment changes.
Write and execute IQ/OQ/PQ and cycle development protocols including final reports.
Maintain an up-to-date knowledge of validation requirements, practices, and procedures.
Write validation plans and risk assessments related to specific projects and facilities.
Facilitate the development of user requirement specifications and operational SOPs for equipment.
Lead cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies.
Develop, review, and revise standard operating procedures and guidelines for product and equipment cleaning.
Other duties as assigned.
Requirements:
Bachelor's Degree or equivalent in a scientific/pharmaceutical area
5+ years of cleaning validation or engineering work in GMP and FDA regulated environment.
Ability to independently generate protocols and reports for evaluation experiments.
Advanced knowledge of various analytical equipment and techniques utilized in an analytical laboratory.
Understanding of regulatory requirements related to cleaning validation and cleaning equipment/CIP design.
Experience in risk management and client service/project management.
Demonstrated ability to work both independently and in a team environment.
Familiarity with production equipment and processing technologies.
Proficient in Microsoft Office programs (Word, Excel, Outlook, CAD) and CRM software.
Travel up to 10%.
Knowledge of EU and other global requirements & standards.
Demonstrated Analytical and Problem-Solving Skills.
Ability to elicit cooperation from a wide variety of sources, including upper management, customers, suppliers, board, and other departments.
Excellent written and oral communication skills.
Ability to lift to 25 pounds.
Ability to work in a dynamic environment with shift priorities.